Roche Diagnostics Tina-Quant Iga GEN.2
FDA 510(k) K040435 · Roche Diagnostics Corp.
510(k) numberK040435
Submission
- Device name
- Roche Diagnostics Tina-Quant Iga GEN.2
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- February 19, 2004
- Decision date
- March 10, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CZP – Iga, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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|---|---|---|---|
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…CZP · Traditional | Horiba Abx SAS | 06/26/2020SE |
| K060130 | Immage Systems Low Concentration Immunoglobulin a ReagentCZP · Special | Beckman Coulter, Inc. | 02/13/2006SE |
| K024038 | N Latex IgaCZP · Traditional | Dade Behring, Inc. | 02/13/2003SE |
| K993927 | Wako Iga Ii-Ha, Immunoglobulin Calibrator Set, Immunoglobulin StandradCZP · Traditional | Wako Chemicals USA, Inc. | 01/14/2000SE |
| K983359 | IgaCZP · Traditional | Abbott Laboratories | 11/04/1998SE |
| K962200 | Quantex IgaCZP · Traditional | Instrumentation Laboratory CO | 09/25/1996SE |
| K955794 | Iga Immunoturbidimetric & CalibratorCZP · Traditional | Randox Laboratories, Ltd. | 04/05/1996SE |
| K955907 | Boehringer Mannheim Iga AssayCZP · Traditional | Boehringer Mannheim Corp. | 02/09/1996SE |
| K952309 | N Latex IgaCZP · Traditional | Behring Diagnostics, Inc. | 06/20/1995SE |
| K931806 | Iga Subclass Rid Kit for Diagnostic UseCZP · Traditional | The Binding Site, Ltd. | 07/16/1993SE |
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| K260046 | Elecsys Anti-HBc IISEI · Traditional | 04/07/2026SE |
| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | 04/02/2026SE |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
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Questions and answers
When was Roche Diagnostics Tina-Quant Iga GEN.2 cleared by the FDA?
Roche Diagnostics Tina-Quant Iga GEN.2 (K040435) received a 510(k) decision of Substantially Equivalent on March 10, 2004, 20 days after the submission was received.
What is the product code of K040435?
The FDA product code is CZP – Iga, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.